PregledMedicinski proizvodi i in vitro dijagnostički medicinski proizvodi igraju glavnu ulogu u spašavanju života tako što pružaju inovativna zdravstvena…DirektiveU EU-u se trenutačno primjenjuju sljedeće direktive o medicinskim proizvodima: Direktiva 98/79/EZ Europskog parlamenta i VijećaNovi propisiEU je revidirao zakonodavne akte o medicinskim proizvodima i in vitro dijagnostici kako bi se uskladio s razvojem sektora u posljednjih 20 godina. Latest updates News announcement12 svibanj 2023UPDATE - MDCG 2020-3 Rev.1 - Guidance on significant changes regarding the transitional provision under Article 120 of the MDR - May 2023News announcement8 svibanj 20232023/C 163/06 - Commission Guidance on the content and structure of the summary of the clinical investigation report - May 2023News announcement21 travanj 2023Meeting audio available - Day 1 & 2: 27-28 March 2023 IMDRF Stakeholder ForumNews announcement21 travanj 2023IMDRF Meeting 24th session - 25-26 September 2023 - Berlin, GermanyPrikaži sve Highlights News announcement5 kolovoz 2022Call for EU reference laboratories sent to Member StatesBenchmarks for high-risk diagnosticsNews announcement21 lipanj 2022Setting the scene for EU reference labs for high-risk diagnostics26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EUNews announcement24 svibanj 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devicesNews announcement26 svibanj 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devicesThe UDI Helpdesk helps economic operators in the implementation of the requirements introduced by the new systemGetting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities Events 25-26ruj2023Konferencije i sastanci na vrhuIMDRF Meeting 24th session - 25-26 September 2023 - Berlin, Germany28ožu2023Konferencije i sastanci na vrhuDay 2: 28 March 2023 IMDRF Stakeholder Forum27ožu2023Konferencije i sastanci na vrhuDay 1: 27 March 2023 Joint IMDRF / Stakeholder (DITTA-GMTA) Workshop07svi2021Partnerski sastanciWebinar for Patients – Safe and performant Medical Devices for all Documents EventsPublications
PregledMedicinski proizvodi i in vitro dijagnostički medicinski proizvodi igraju glavnu ulogu u spašavanju života tako što pružaju inovativna zdravstvena…
DirektiveU EU-u se trenutačno primjenjuju sljedeće direktive o medicinskim proizvodima: Direktiva 98/79/EZ Europskog parlamenta i Vijeća
Novi propisiEU je revidirao zakonodavne akte o medicinskim proizvodima i in vitro dijagnostici kako bi se uskladio s razvojem sektora u posljednjih 20 godina.
News announcement12 svibanj 2023UPDATE - MDCG 2020-3 Rev.1 - Guidance on significant changes regarding the transitional provision under Article 120 of the MDR - May 2023
News announcement8 svibanj 20232023/C 163/06 - Commission Guidance on the content and structure of the summary of the clinical investigation report - May 2023
News announcement21 travanj 2023Meeting audio available - Day 1 & 2: 27-28 March 2023 IMDRF Stakeholder Forum
26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EU
News announcement24 svibanj 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices
News announcement26 svibanj 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices
The UDI Helpdesk helps economic operators in the implementation of the requirements introduced by the new system
Getting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities
25-26ruj2023Konferencije i sastanci na vrhuIMDRF Meeting 24th session - 25-26 September 2023 - Berlin, Germany
27ožu2023Konferencije i sastanci na vrhuDay 1: 27 March 2023 Joint IMDRF / Stakeholder (DITTA-GMTA) Workshop
